Thyroid NeoplasmsPhase 2/3NCT02418247
Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer
A Phase 2/3 study testing I131 and I123 in people with Thyroid Neoplasms, run by National Cancer Center, Korea at 5 sites in South Korea.
Trial summary
The researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentiated thyroid cancer patients who underwent total thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Thyroid Neoplasms
- What is being tested?
- I131 and I123
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 556 participants
- Where
- 5 sitesSouth Korea
- Study dates
- May 2013to Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with differentiated thyroid cancer
- recently underwent total thyroidectomy (within 6 months)
- pathological criteria
- T1bN0 : Tumor size 1-2cm with no microscopic extension with multifocality (within three foci)
- T3N0 : Tumor size <=2cm with microscopic extension (less than strap muscle)
- T1-3N1a : 3 or less micrometastatic lymph node
Who cannot join
- differentiated thyroid cancer with aggressive variant, poorly differentiated thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer
- gross extension (strap muscle or more)
- thyroid cancer with distant metastasis
- previous remote history of thyroid cancer surgery
- history of cervical external beam radiation therapy
- previous history of comorbid cancer within 5 years
- renal insufficiency (Ccr <30ml/min)
- women with pregnancy or breast feeding
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Chungnam National University Hospital
Daejun
National Cancer Center, Korea
Goyang
Seoul National University Boramae Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul National University Bundang Hospital
Sungnam
About this study
Official title: Phase Ⅱ Non-randomized Multicenter Controlled Trial About Effect of Remnant Ablation Therapy on the Recurrence in Low-risk Differentiated Thyroid Cancer Patients
The researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentiated thyroid cancer patients who underwent total thyroidectomy.
- Conditions
- Thyroid Neoplasms
- Being tested
- I131, I123
- Keywords
- radioactive iodine therapy, ablation, thyroid cancer
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I131Drug
Also called low dose RAI
I123Drug
Also called diagnostic RAI
| Study group | Role | What they receive |
|---|---|---|
| low dose RAI | Active comparator | Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue. Receives: Drug: I131 |
| diagnostic RAI | Sham comparator | Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan. Receives: Drug: I123 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Remission Rate
Measured: within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startMay 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eun Kyung Lee, National Cancer Center, Korea
- Investigators
- Eun Kyung Lee, M.D.,Ph.D., Study chair, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418247
- Sponsor's protocol ID
- NCCCTS13-671
- Other IDs
- 1410650-1,2
- Status last verified
- Jan 2017
- First submitted
- 13 Apr 2015
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅱ Non-randomized Multicenter Controlled Trial About Effect of Remnant Ablation Therapy on the Recurrence in Low-risk Differentiated Thyroid Cancer Patients
- ClinicalTrials.gov ID
- NCT02418247
- Acronym / sponsor ID
- NCCCTS13-671
- Conditions
- Thyroid Neoplasms
- Keywords
- radioactive iodine therapy, ablation, thyroid cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- May 2013 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentiated thyroid cancer patients who underwent total thyroidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose RAI | Active comparator | Drug: I131Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue. |
| diagnostic RAI | Sham comparator | Drug: I123Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with differentiated thyroid cancer
- recently underwent total thyroidectomy (within 6 months)
- pathological criteria
Key exclusion criteria (8 listed)
- differentiated thyroid cancer with aggressive variant, poorly differentiated thyroid cancer, medullary thyroid cancer, anaplastic thyroid cancer
- gross extension (strap muscle or more)
- thyroid cancer with distant metastasis
- previous remote history of thyroid cancer surgery
- history of cervical external beam radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I131Also: low dose RAI | Drug | low dose RAI |
| I123Also: diagnostic RAI | Drug | diagnostic RAI |
Primary outcome
Biochemical Remission Rate
Time frame: within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun Kyung Lee, M.D.,Ph.D. study chair
National Cancer Center, Korea
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing I131 and I123 in people with Thyroid Neoplasms, run by National Cancer Center, Korea at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Remission Rate (time frame: within 1 year since first thyroid hormone withdrawal regardless of radioactive iodine administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.